Accupril (Quinapril HCl Tablets) 20 mg, 90 Tablets, Rx only NDC 0071-0532-23 Distributed by: Par...
FDA Recall #D-0873-2022 — Class II — April 22, 2022
Product Description
Accupril (Quinapril HCl Tablets) 20 mg, 90 Tablets, Rx only NDC 0071-0532-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017
Reason for Recall
CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
Recalling Firm
Pfizer Inc. — New York, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
10,304 bottles
Distribution
Nationwide and Puerto Rico
Code Information
Lots: DX8682 Exp. MAR 31 2023; DG1188 Exp. MAR 31 2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated